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临床试验 NCT05887583 (SPLASH) 针对身体不活动目前进行中但不再招募。请查看临床试验雷达卡片视图和 AI 发现工具了解所有详情，或在此提出任何问题。 | ||
塔夫茨大学Supporting Physical Literacy at School and Home (SPLASH)
- The impact of the multilevel program on children's physical literacy and physical activity over one school year. Hypothesis:
- Whether the program effects are different by children's gender or weight status
- Whether changes in children's ability, confidence and motivation for physical activity are related to changes in physical activity levels.
Schools will be randomly assigned to receive the multilevel intervention or a control group.
Participants in the intervention group will receive a new school curriculum during regular physical education classes and information for families on what school activities can be done at home.
Researchers will compare outcomes according to intervention and control group assignments.
Aims include testing the multilevel Rising New York Road Runners (RNYRR) program using a 2-arm, group randomized controlled trial (RCT) with n=400 3rd-5th grade students from low-income schools receiving either the multilevel RNYRR program (n=4) or delayed-intervention control (n=4).
Aim 3: To evaluate the impact of the RNYRR program on children's physical literacy (PL) and physical activity (PA) (total daily volume and moderate-to-vigorous PA (MVPA)) over one school year. Hypothesis: Children who attend schools with the RNYRR programming will increase PL and PA (total daily volume and MVPA) relative to children in control schools.
Aim 3a: To examine whether RNYRR program effects on children's PL and PA differ by sex or weight status.
Aim 3b: To test whether changes in PL and PL subdomains (e.g. ability, confidence, motivation) mediate changes in daily total PA volume or MVPA.
Supporting Physical Literacy at School and Home (SPLASH) Study
- SPLASH
- STUDY00003794
| 参与者组/试验组 | 干预措施/治疗方法 |
|---|---|
实验性Intervention The Rising New York Road Runners program: A School-based physical education curriculum with family engagement component. | The Rising New York Road Runners Program The Rising New York Road Runners program provides lesson plans covering fundamental movement skills that are intended to build competence, confidence, and motivation to be physically activity. Family engagement materials (emails, text messages, videos, social media) complement school materials to communicate what children are learning at school related to physical activity and what activities families can do at home together to reinforce these concepts. |
无干预Control Standard school operating procedures | 不适用 |
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
Baseline physical activity level | Children will wear an Actigraph accelerometer for 7 days on their right hip at study baseline (prior to intervention). The accelerometer measures vertical acceleration across three planes and computes a total volume of movement over a specified amount of time set by the researcher. This information will also be used to computer time spent in intensity-specific physical activity using established cutpoints. | +/- 4 weeks prior to study intervention |
End-point physical activity level | Children will wear an Actigraph accelerometer for 7 days on their right hip at study baseline (prior to intervention). The accelerometer measures vertical acceleration across three planes and computes a total volume of movement over a specified amount of time set by the researcher. This information will also be used to computer time spent in intensity-specific physical activity using established cutpoints. | +/- 4 weeks prior to study completion |
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
Baseline fundamental movement skill in running, locomotion, object control and Balance | Trained staff will administer the Physical Literacy Assessment for Youth tool to assess children's performance across 18 different tasks that assess competence in fundamental movement skill domain areas: Running, locomotion, object control and balance. | +/- 4 weeks prior to study intervention |
End-point fundamental movement skill in running, locomotion, object control and Balance | Trained staff will administer the Physical Literacy Assessment for Youth tool to assess children's performance across 18 different tasks that assess competence in fundamental movement skill domain areas: Running, locomotion, object control and balance. | +/- 4 weeks prior to study completion |
- Child attends school participating in the intervention
- In the 3rd, 4th or 5th grade
- Participates in the school's physical education class
- Not in the 3rd, 4th or 5th grade
- Does not participate in the school's physical education class
塔夫茨大学55 个活跃的临床试验可供探索乔治·华盛顿大学80 个活跃的临床试验可供探索Massachusetts